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Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

Recruiting
2 - 70 years of age
Both
Phase N/A

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Overview

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

Description

The CARs consist of an anti-CD7 single-chain variable fragment(scFv), a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Eligibility

Inclusion Criteria:

  1. Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred;
  2. CD7 expression in tumor cells was detected by flow cytometry;
  3. Life expectancy greater than 12 weeks;
  4. KPS or Lansky score≥60;
  5. HGB≥70g/L (can be transfused);
  6. 2-70 years old;
  7. Oxygen saturation of blood#90%#;
  8. HGB≥70g/L(blood transfusion allowed);
  9. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
  10. Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion Criteria:

  1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
  2. Has an active GvHD;
  3. Has a history of severe pulmonary function damaging;
  4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  5. Severe or persistent infection that cannot be effectively controlled;
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
  8. Patients with HIV infection or syphilis infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;
  11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
  12. Have received transplant treatment for less than 6 months in prior to enrollment;
  13. Being pregnant and lactating or having pregnancy within 12 months;
  14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Study details

T-cell Acute Lymphoblastic Leukemia/Lymphoma

NCT05626400

Hebei Senlang Biotechnology Inc., Ltd.

25 January 2024

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